1. Field of the Invention
The present invention relates to an assay apparatus, and particularly to an assay apparatus for performing a predetermined assay using a reaction container that holds a specimen, and a method for controlling the assay apparatus.
Further, the present invention relates to a reaction container that holds a specimen, and which is used in such an assay apparatus.
2. Description of the Related Art
In recent years, many devices for assay that can easily and quickly test an analyte by using an assay method, such as immunoassay, were developed. In such devices for assay, a specimen (sample) that may contain an analyte is held by a carrier, and assayed. Further, various devices for testing in-vitro diagnostic reagents, toxic substances or the like are commercially available. Some example of such devices uses immunochromatography, as disclosed in Japanese Unexamined Patent Publication No. 2008-139297 (Patent Document 1). When a device adopting immunochromatography is used, an assay result is obtainable by leaving a specimen solution held by a carrier for only about 5 to 10 minutes at the shortest. Therefore, assay techniques using assay methods, such as immunoassay, are widely adopted as simple and quick assay techniques, for example, in a clinical test at a hospital, an assay test at a laboratory, or the like.
Especially, in medical care situations at a doctor's office, a clinic, home and the like, many immunochromatographic assay apparatuses (immunochromato-readers) are used as assay devices for POCT (Point of Care Testing) care. In POCT, a simple assay is possible without relying on a clinical test specialist. The immunochromatographic assay apparatus can measure the color-developed state of a reagent in a device loaded into the apparatus at high sensitivity. Therefore, even if the color-developed state is too low to visually judge the state, a highly sensitive and reliable assay is possible. Japanese Unexamined Patent Publication No. 2009-133813 (Patent Document 2) discloses an example of this kind of assay apparatus.
In the aforementioned assay methods, it is necessary to detect an extremely small amount of analyte at high sensitivity. As an assay method satisfying such a need, a method that performs amplification (sensitization), for example, as disclosed in Japanese Unexamined Patent Publication No. 2009-287952 (Patent Document 3) is known. In this method, after an analyte is developed on a carrier, washing liquid is supplied to wash away everything except a labeling substance captured by binding to a specific reaction site on the carrier. After then, a sensitizing solution is supplied onto the carrier to sensitize the labeling substance. Accordingly, a very small amount of analyte becomes detectable at high sensitivity.
Here, the aforementioned sensitizing process may be performed only if necessary. In other words, if the color-developed state of a reagent has been measured by ordinary processing, measurement may end. If the color-developed state is not measurable by ordinary processing, the sensitizing process may be performed, and the color-developed state may be measured after the sensitizing process.
The aforementioned carrier is used by being held in a reaction container that is called as a cartridge, a package, an assay kit, or the like in general. Japanese Unexamined Patent Publication No. 2007-101364 (Patent Document 4) discloses an example of such a kind of reaction container. As disclosed also in Patent Document 4, a protective sheet is often provided for the reaction container to prevent leakage or quality change of a reagent or the like that is held in advance in the reaction container. The protective sheet is broken by the assay apparatus to make use of the reagent or the like during use of the reaction container. Therefore, it is possible to judge whether the reaction container has already been used or the reaction container has not been used by checking whether this protective sheet is broken.